Trial Outcomes & Findings for Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest (NCT NCT02974257)
NCT ID: NCT02974257
Last Updated: 2025-04-10
Results Overview
The investigators will evaluate the median lactate level over two days, compared between groups
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
2 days
Results posted on
2025-04-10
Participant Flow
Participant milestones
| Measure |
Thiamine
Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
Thiamine: Thiamine 500mg IV twice daily for 2 days
|
Placebo
Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
placebo: 100mL normal saline IV every 12 hours for 2 days
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Thiamine
Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
Thiamine: Thiamine 500mg IV twice daily for 2 days
|
Placebo
Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
placebo: 100mL normal saline IV every 12 hours for 2 days
|
|---|---|---|
|
Overall Study
Transitioned to comfort-measures only prior to meeting fraction of inspired oxygen (FiO2) criteria
|
1
|
0
|
|
Overall Study
Clinical indication for thiamine
|
1
|
0
|
|
Overall Study
Already on thiamine
|
1
|
0
|
|
Overall Study
Extubated prior to study drug
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest
Baseline characteristics by cohort
| Measure |
Thiamine
n=18 Participants
Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
Thiamine: Thiamine 500mg IV twice daily for 2 days
|
Placebo
n=18 Participants
Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
placebo: 100mL normal saline IV every 12 hours for 2 days
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
72.5 years
n=7 Participants
|
69.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other/Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Initial Rhythm
Pulseless Electrical Activity
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Initial Rhythm
Asystole
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Initial Rhythm
Ventricular Fibrillation/Pulseless Ventricular Tachycardia
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Minutes to Return of Spontaneous Circulation (ROSC)
|
11 minutes
n=5 Participants
|
10.5 minutes
n=7 Participants
|
11 minutes
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 daysPopulation: A total of 5 patients in the thiamine group and 4 patients in placebo group missing lactate at 48-hours due to death; these values were imputed using a 20 percent increase prior to calculating the below medians and IQRs. There was one additional patient in the thiamine group whose lactate at 48-hours was not imputed as it was missing due to non-death reasons, leading to n = 17 for thiamine (instead of 18).
The investigators will evaluate the median lactate level over two days, compared between groups
Outcome measures
| Measure |
Thiamine
n=17 Participants
Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
Thiamine: Thiamine 500mg IV twice daily for 2 days
|
Placebo
n=18 Participants
Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
placebo: 100mL normal saline IV every 12 hours for 2 days
|
|---|---|---|
|
Lactate
|
1.9 mmol/L
Interval 1.1 to 7.5
|
1.8 mmol/L
Interval 1.2 to 5.4
|
SECONDARY outcome
Timeframe: 2 daysPopulation: 22 patients had metabolic data at 48 hours, n = 11 in placebo, n = 11 in thiamine
The investigators will evaluate the mean oxygen consumption over two days, compared between groups
Outcome measures
| Measure |
Thiamine
n=11 Participants
Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
Thiamine: Thiamine 500mg IV twice daily for 2 days
|
Placebo
n=11 Participants
Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
placebo: 100mL normal saline IV every 12 hours for 2 days
|
|---|---|---|
|
Oxygen Consumption
|
3.83 Area under the Curve VO2 (mL/kg/min)
Standard Deviation 0.94
|
3.48 Area under the Curve VO2 (mL/kg/min)
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Only 12 patients in Thiamine and 13 patients in Placebo alive and with non-missing PDH specific activity values at 48-hours.
The investigators will evaluate the median pyruvate dehydrogenase levels over two days, compared between groups
Outcome measures
| Measure |
Thiamine
n=12 Participants
Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
Thiamine: Thiamine 500mg IV twice daily for 2 days
|
Placebo
n=13 Participants
Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
placebo: 100mL normal saline IV every 12 hours for 2 days
|
|---|---|---|
|
Pyruvate Dehydrogenase
|
1.2 mini OD unit/min/mg protein
Interval 0.9 to 1.5
|
1.1 mini OD unit/min/mg protein
Interval 1.0 to 1.3
|
Adverse Events
Thiamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place